NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the
company will present late-breaking data from Phase 3 studies evaluating
TRULANCE™ (plecanatide) for the treatment of adults with irritable bowel
syndrome with constipation (IBS-C) at Digestive Disease Week (DDW), May
6-9, 2017, in Chicago.

TRULANCE is a once-daily tablet approved by the Food and Drug
Administration (FDA) for the treatment of adults with chronic idiopathic
constipation (CIC) and is currently being evaluated for the treatment of
adults with IBS-C. The recommended dosage of TRULANCE for CIC is 3 mg
taken orally, once daily, with or without food at any time of the day.

In two large Phase 3 studies of more than 2,100 total patients with
IBS-C, TRULANCE 3 mg and 6 mg doses met the primary endpoint showing
statistical significance in the percentage of patients who were Overall
Responders compared to placebo during the 12-week treatment period
(Study 1: 30.2% in 3 mg and 29.5% in 6 mg dose groups compared to 17.8%
in placebo; p<0.001 for 3 mg and p<0.001 for 6 mg; Study 2:21.5% in 3 mg and 24.0% in 6 mg dose groups compared to 14.2% in
placebo; p=0.009 for 3 mg and p<0.001 for 6 mg).

An Overall Responder, as defined by the U.S. Food and Drug
Administration (FDA), is a patient who fulfills both ≥ 30% reduction in
worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel
movement (CSBM) over baseline, in the same week, for at least 50% of the
12 treatment weeks.

“The data presented today supports the potential use of TRULANCE in
patients with IBS-C, a population who often face a range of physical
symptoms,” said Ronald Fogel, M.D., Clinical Research Institute of
Michigan. “People living with IBS-C often attempt to manage symptoms
before seeing a healthcare provider, which can delay appropriate
treatment. Yet even after seeking regular care, patients may still be
searching for an appropriate option to manage their IBS-C symptoms.”

In a pooled analysis of both studies, a statistically significant
percentage of patients treated with TRULANCE achieved at least a 30
percent reduction in abdominal intensity pain compared to placebo for at
least six weeks of the 12-week treatment period (36.8% in 3 mg and 39.1%
in 6 mg dose groups compared to 27.3% in placebo; p<0.001). A
statistically significant percentage of patients treated with TRULANCE
also saw improvement in stool frequency compared to placebo for at least
six weeks of the 12-week treatment period, as measured by an increase in
at least one CSBM per week from baseline (40.9% in 3 mg and 41.9% in
6 mg dose groups compared to 31.4% in placebo; p<0.001).

In both studies, treatment with TRULANCE also resulted in a
significantly greater percentage of sustained efficacy responders, as
measured by patients who were Overall Responders in the last two of four
weeks of treatment (24.3% in 3 mg and 25.5% in 6 mg dose groups compared
to 15.6% in placebo; p<0.001).

“We are thrilled to be able to present a wide range of new data at DDW
in irritable bowel syndrome with constipation, including new results
evaluating abdominal pain intensity and stool frequency,” said Patrick
H. Griffin, M.D., EVP and Chief Medical Officer of Synergy
Pharmaceuticals Inc. “Findings presented this week add to the efficacy
and safety data previously presented supporting TRULANCE as a potential
treatment for IBS-C and symbolizes our commitment to developing a new
treatment option for patients living with this common functional GI
disorder.”

In both studies, the most common adverse event was diarrhea (4.3% at 3
mg and 4.0% at 6 mg compared to 1.0% for placebo), with severe diarrhea
rates that were low across both groups in both studies (1.0% at 3 mg and
0.4% at 6 mg, compared to 0.1% for placebo). Discontinuation rates were
low across both groups and discontinuations due to diarrhea were
infrequent (1.2% at 3 mg and 1.4% at 6 mg compared to no patients for
placebo).

On March 27, 2017, Synergy announced that the company submitted a
supplemental New Drug Application (sNDA) for TRULANCE for the treatment
of adults with IBS-C in the United States.

Indications and Usage

TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for
the treatment of chronic idiopathic constipation (CIC).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

Trulance™ is contraindicated in patients less than 6 years of age; in
nonclinical studies in young juvenile mice administration of a single
oral dose of plecanatide caused deaths due to dehydration. Use of
Trulance should be avoided in patients 6 years to less than 18 years of
age. The safety and efficacy of Trulance have not been established in
pediatric patients less than 18 years of age.

Contraindications

Trulance is contraindicated in patients less than 6 years of age due
to the risk of serious dehydration.

Trulance is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.

Warnings and Precautions

Risk of Serious Dehydration in Pediatric Patients

Trulance is contraindicated in patients less than 6 years of age. The
safety and effectiveness of Trulance in patients less than 18 years of
age have not been established. In young juvenile mice (human age
equivalent of approximately 1 month to less than 2 years), plecanatide
increased fluid secretion as a consequence of stimulation of guanylate
cyclase-C (GC-C), resulting in mortality in some mice within the first
24 hours, apparently due to dehydration. Due to increased intestinal
expression of GC-C, patients less than 6 years of age may be more
likely than older patients to develop severe diarrhea and its
potentially serious consequences.

Use of Trulance should be avoided in patients 6 years to less than 18
years of age. Although there were no deaths in older juvenile mice,
given the deaths in young mice and the lack of clinical safety and
efficacy data in pediatric patients, use of Trulance should be avoided
in patients 6 years to less than 18 years of age.

Diarrhea

Diarrhea was the most common adverse reaction in the two
placebo-controlled clinical trials. Severe diarrhea was reported in
0.6% of patients.

If severe diarrhea occurs, the health care provider should suspend
dosing and rehydrate the patient.

Adverse Reactions

In the two combined CIC clinical trials, the most common adverse
reaction in Trulance-treated patients (incidence ≥2% and greater than
in the placebo group) was diarrhea (5% vs 1% placebo).

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder
characterized by recurrent abdominal pain and associated with two or
more of the following: related to defecation, associated with a change
in the frequency of stool, or associated with a change in the form
(appearance) of the stool. IBS can be subtyped by the predominant stool
form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M).Those
within the IBS-C subtype experience hard or lumpy stools more than 25
percent of the time they defecate, and loose or watery stools less than
25 percent of the time.It is estimated that the prevalence
of IBS-C in the U.S. adult population is approximately 4 to 5 percent,
although this number can vary as patients may fluctuate between the
three subtypes of IBS.

About TRULANCE™

TRULANCE™ (plecanatide) is a once-daily tablet approved for
adults with CIC and is being evaluated for IBS-C. With the exception of
a single amino acid substitution for greater binding affinity, TRULANCE
is structurally identical to uroguanylin, a naturally occurring and
endogenous human GI peptide. Uroguanylin activates GC-C receptors in a
pH-sensitive manner primarily in the small intestine, stimulating fluid
secretion and maintaining stool consistency necessary for regular bowel
function.

About Synergy Pharmaceuticals

Synergy is a biopharmaceutical company focused on the development and
commercialization of novel GI therapies. The company has pioneered
discovery, research and development efforts on analogs of uroguanylin, a
naturally occurring and endogenous human GI peptide, for the treatment
of GI diseases and disorders. Synergy’s proprietary GI platform includes
one commercial product TRULANCE and a second lead product candidate,
dolcanatide. For more information, please visit www.synergypharma.com.

Forward-Looking Statement

This press release and any statements made for and during any
presentation or meeting contain forward-looking statements related to
Synergy Pharmaceuticals Inc. under the safe harbor provisions of Section
21E of the Private Securities Litigation Reform Act of 1995 and are
subject to risks and uncertainties that could cause actual results to
differ materially from those projected. These statements may be
identified by the use of forward-looking words such as "anticipate,"
"planned," "believe," "forecast," "estimated," "expected," and "intend,"
among others. There are a number of factors that could cause actual
events to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, the
development, launch, introduction and commercial potential of TRULANCE;
growth and opportunity, including peak sales and the potential demand
for TRULANCE, as well as its potential impact on applicable markets;
market size; substantial competition; our ability to continue as a going
concern; our need for additional financing; uncertainties of patent
protection and litigation; uncertainties of government or third party
payer reimbursement; dependence upon third parties; our financial
performance and results, including the risk that we are unable to manage
our operating expenses or cash use for operations, or are unable to
commercialize our products, within the guided ranges or otherwise as
expected; and risks related to failure to obtain FDA clearances or
approvals and noncompliance with FDA regulations. As with any
pharmaceutical under development, there are significant risks in the
development, regulatory approval and commercialization of new products.
There are no guarantees that future clinical trials discussed in this
press release will be completed or successful or that any product will
receive regulatory approval for any indication or prove to be
commercially successful. Investors should read the risk factors set
forth in Synergy's most recent periodic reports filed with the
Securities and Exchange Commission, including Synergy’s Form 10-K for
the year ended December 31, 2016. While the list of factors presented
here is considered representative, no such list should be considered to
be a complete statement of all potential risks and uncertainties.
Unlisted factors may present significant additional obstacles to the
realization of forward-looking statements. Forward-looking statements
included herein are made as of the date hereof, and Synergy does not
undertake any obligation to update publicly such statements to reflect
subsequent events or circumstances except as required by law.